Orthognathic implant and methods of use

ABSTRACT

An implant for use in orthognathic surgery of a mandible may include a longitudinal plate member and a plurality of pre-configured guides coupled to the plate member. The longitudinal plate member is pre-bent to correspond to the post-operative shape of the mandible; and the guides are pre-configured to align the plate member with the mandible when the implant is positioned against the mandible after the mandible has been separated.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.15/828,568 filed Dec. 1, 2017, which is a divisional of U.S. patentapplication Ser. No. 15/010,553 filed Jan. 29, 2016, which is acontinuation of U.S. patent application Ser. No. 13/855,802 filed Apr.3, 2013, now U.S. Pat. No. 9,277,948 issued on Mar. 8, 2016, which is adivisional of U.S. patent application Ser. No. 13/078,250 filed Apr. 1,2011, now U.S. Pat. No. 8,435,270 issued on May 7, 2013, which is acontinuation-in-part of U.S. patent application Ser. No. 12/770,088filed Apr. 29, 2010, now U.S. Pat. No. 9,066,733 issued on Jun. 30,2015, the disclosures of each of which are hereby incorporated byreference as if set forth in their entireties herein.

BACKGROUND

Orthognathic surgery is generally performed to correct conditions of thejaw (i.e. the mandible), maxilla, and face related to structure, growth,sleep apnea, TMJ disorders or to correct orthodontic problems. Forexample, an individual who has a significantly receded upper jaw or anopen bite might benefit from a maxillary osteotomy. In such a procedure,a surgeon makes cuts below both eye sockets to separate a segmented partof the maxilla from an intact portion of the maxilla. The entiresegmented part, including the roof of the mouth and all upper teeth, canmove as a single unit. The segmented part is then moved until the upperand bottom teeth fit together properly. Once the teeth are realigned,tiny screws and plates are used to fix the segmented part of the maxillain its new position until natural bone healing takes place.

Some orthognathic surgeries affix multiple plates to the maxilla to holdthe cut segmented part of the maxilla relative to the second intactpart. As one could imagine, the adaptation and use of multiple platesmake the procedure unnecessarily long and complicated.

Similarly, an individual may require a mandible reconstruction due totrauma or a tumor. To remove the tumor, the surgeon may cut the mandibleon either side of the tumor thereby separating the tumor from themandible. Once the tumor is removed, the mandible is separated into afirst part and a second part. If needed, the first part and/or thesecond part may be repositioned and tiny screws and plates are used tofix the first part and the second part together until natural bonehealing takes place.

Other plating systems for orthognathic surgeries involving the maxillaand the mandible require multiple disciplines such as surgeons,dentists, orthodontists, etc to complete the procedure. As a resultthere often times are misunderstandings between the disciplines. Theseand other disadvantages are attributed to such plating systems used inorthognathic surgeries.

Therefore, it may be desired to achieve a better and more accurate wayof planning and performing orthognathic surgery.

SUMMARY

The disclosure generally relates to an improvement in implants used inorthognathic surgery, and in particular, patient specific plates for usein orthognathic surgery. However, the disclosed implants are not limitedto this specific application.

In one embodiment, an implant is configured to fix at least a firstmandibular bone part relative to a second mandibular bone part that isseparated from the first mandibular bone part by a bone gap. The boneimplant may include a plate member and at least one guide coupled to theplate member. The plate member may include a pre-operatively bent bodyhaving a shape corresponding to a post-operative shape of a mandiblewhen aligned with the mandible. The plate member defining at least onefixation aperture that extends through the pre-operatively bent body andis configured to receive a bone fixation element so as to secure theplate member to the mandible. The at least one guide may bepre-operatively configured to align the plate member with the mandiblewhen the implant is positioned against the mandible after the mandiblehas been separated so as to define the bone gap.

A method of customizing a pre-configured implant configured to fix atleast a first mandibular bone part relative to a second mandibular bonepart that is separated from the first mandibular bone part by a bonegap. To customize the implant a pre-operative 3-D model of a patient'smandible is first obtained in a computer, whereby a first part of themandible and a second part of the mandible define a first relativeposition. The pre-operative 3-D model of the mandible is the manipulatedinto a planned post-operative shape whereby the first part of themandible and the second part of the mandible define a second relativeposition. Once in the desired position a bone fixation implant is customconstructed to match the planned post-operative shape of the mandible.The implant may include a plate member pre-bent to attach to the firstpart and the second part of the mandible, and at least one guide coupledto the plate member. The guide may be pre-configured so as to align theplate member with the mandible when the implant is positioned againstthe mandible after the mandible has been separated so as to define thebone gap.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing summary, as well as the following detailed description ofexample embodiments, are better understood when read in conjunction withthe appended diagrammatic drawings. For the purpose of illustrating theinvention, the drawings show embodiments that are presently preferred.The invention is not limited, however, to the specific instrumentalitiesdisclosed in the drawings.

FIG. 1 is a perspective view of a skull with a bone fixation implantaffixed to the maxilla;

FIG. 2A is a perspective view of a bone fixation implant constructed inaccordance with one embodiment;

FIG. 2B is a front elevation view of the bone fixation implant shown inFIG. 2A;

FIG. 2C is a top plan view of the bone fixation implant shown in FIG.2A;

FIG. 2D is a left side elevation view of the bone fixation implant shownin FIG. 2A;

FIG. 3A is a perspective view of an osteotomy guiding implantconstructed in accordance with one embodiment;

FIG. 3B is a front elevation view of the osteotomy guiding implant shownin FIG. 3A;

FIG. 3C is a top plan view of the osteotomy guiding implant shown inFIG. 3A;

FIG. 3D is a left side elevation view of the osteotomy guiding implantshown in FIG. 3A;

FIG. 4 is a diagram showing the process for customizing the bonefixation implant of FIGS. 2A-2D and the osteotomy guiding implant ofFIGS. 3A-3D to correspond to an individual patient's maxilla;

FIG. 5A is a front elevation view of a skull, including a maxilla bonethat is to be operated on;

FIG. 5B is an enlarged detailed view showing the pre-operative shape ofthe maxilla of the skull shown in FIG. 5A;

FIG. 5C is a front elevation view of the maxilla shown in FIG. 5B,showing the osteotomy guiding implant of FIGS. 3A-3D being attached tothe maxilla;

FIG. 5D is a front elevation view of the of the maxilla shown in FIG.5C, showing holes being drilled into the maxilla through guide holesdefined by the osteotomy guiding implant;

FIG. 5E is a front elevation view of the maxilla shown in FIG. 5D,showing the drilled holes;

FIG. 5F is a front elevation view of the maxilla shown in FIG. 5E,showing the osteotomy performed on the maxilla, using the holes as acutting guide;

FIG. 5G is a front elevation view of the maxilla shown in FIG. 5F,showing a segmented portion of the maxilla being repositioned into apost-operative shape;

FIG. 5H is a front elevation view of the maxilla shown in FIG. 5G,showing the bone fixation implant of FIGS. 2A-2D being attached to themaxilla;

FIG. 5I is a front elevation view of the maxilla shown in FIG. 5H,showing the bone fixation implant attached to the maxilla;

FIG. 5J is a front elevation view of the maxilla shown in FIG. 51,showing a bridge portion of the bone fixation implant removed;

FIG. 6 is a perspective view of a bone fixation implant in accordancewith another embodiment, the bone fixation implant configured to beaffixed to a mandible that has been separated into a first part and asecond part;

FIG. 7A is a perspective view of the bone fixation implant shown in FIG.6, the bone fixation implant including a plate member and a plurality ofguides coupled to the plate member;

FIG. 7B is an exploded view of the guide shown in FIG. 7A, the guideincluding a guide body, a channel extending through the guide body andconfigured to receive the plate member, a transverse aperture extendingtransversely through the guide body, and a pusher translatable withinthe transverse aperture;

FIG. 7C is a partial top plan view of one of the guides coupled to theplate member;

FIG. 7D is a sectional side elevation view of the guide shown in FIG. 7Cthrough the line 7D-7D;

FIG. 7E is a sectional side elevation view of the guide shown in FIG. 7Cthrough the line 7E-7E;

FIG. 8A is a perspective view of a guide constructed in accordance withanother embodiment and for use with the implant shown in FIG. 6, theguide configured to be pre-shaped to correspond to a surface of themandible;

FIG. 8B is a sectional top plan view of the guide shown in FIG. 8A;

FIG. 8C is a sectional side elevation view of the guide show in FIG. 8A;

FIG. 9A is a perspective view showing the pre-operative shape of amandible;

FIG. 9B is a perspective view of the mandible shown in FIG. 9A, afterthe mandible has been segmented into a first part and a second part;

FIG. 9C is a perspective view of the bone fixation implant of FIGS.7A-7E being attached to the first and second parts of the mandible;

FIG. 9D is a perspective view of the bone fixation implant fullyattached to the first and second parts of the mandible; and

FIG. 9E is a perspective view of the bone fixation implant fullyattached to the first and second parts of the mandible with the guidesremoved.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

Referring to FIG. 1 a bone fixation implant 10 to be used inorthognathic surgery is designed to be fixed to underlying bone such asa patient's skull 12, and in particular to a patient's maxilla 14 afterthe maxilla 14 has been separated into a first “segmented” part 18 and asecond “integral” part 22 by a segmentation procedure, such as anosteotomy. The first part 18 of the maxilla 14 typically carries theupper teeth and is completely separated from the skull 12 after theosteotomy has been performed, while the second part 22 of the maxilla 14remains intact with the skull 12. The bone fixation implant 10 isconfigured to attach to the first and second parts of the maxilla, andthereby support and hold the first part 18 of the maxilla relative tothe second part 22 while osteogenesis occurs. The implant 10 iscustomized pre-operatively to minimize complications during surgery andtime spent in the operating room by a patient.

Certain terminology is used in the following description for convenienceonly and is not limiting. The words “right”, “left”, “lower” and “upper”designate directions in the drawings to which reference is made. Thewords “inner” or “distal” and “outer” or “proximal” refer to directionstoward and away from, respectively, the geometric center of the implantand related parts thereof. The words, “anterior”, “posterior”,“superior,” “inferior,” “medial,” “lateral,” and related words and/orphrases designate preferred positions and orientations in the human bodyto which reference is made and are not meant to be limiting. Theterminology includes the above-listed words, derivatives thereof andwords of similar import.

Referring to FIGS. 2A-2D, the implant 10 and various components of theimplant are described herein extending horizontally along a longitudinaldirection “L” and lateral direction “A”, and vertically along atransverse direction “T”. Unless otherwise specified herein, the terms“lateral,” “longitudinal,” and “transverse” are used to describe theorthogonal directional components of various components. When theimplant 10 is implanted onto a maxilla, such as the maxilla 14, thetransverse direction T extends vertically generally along thesuperior-inferior (or caudal-cranial) direction, while the plane definedby the longitudinal direction L and lateral direction A extendshorizontally, generally in the anatomical plane defined by themedial-lateral direction and the anterior-posterior direction.Accordingly, the directional terms “vertical” and “horizontal” are usedto describe the implant 10 and its components as illustrated merely forthe purposes of clarity and illustration.

As shown in FIGS. 2A-2D, the bone fixation implant 10 includes alongitudinal plate member 30 that is elongate and curved in thelongitudinal direction L and a holding structure 34 that extendsvertically from the longitudinal member 30. The longitudinal platemember 30 includes an upper edge 38, a bone engaging surface configuredto lie substantially flush with the maxilla, and an outer surfaceopposed to the bone engaging surface. Therefore, the holding structure34 extends up from the upper edge 38 of the longitudinal member 30. Asshown in FIG. 1, the bone fixation implant 10 supports and holds thefirst part 18 of the maxilla relative to the second part 22 whileosteogenesis occurs. The bone fixation implant 10 and componentsthereof, can be formed from a variety of biocompatible materials, suchas cobalt chromium molybdenum (CoCrMo), titanium, and titanium alloys,stainless steel, ceramics, or polymers such as polyetheretherketone(PEEK), polyetherketoneketone (PEKK), and bioresorbable materials. Acoating may be added or applied to the bone fixation implant 10 toimprove physical or chemical properties or to provide medications.Examples of coatings include plasma-sprayed titanium coating orHydroxyapatite.

As shown in FIGS. 1, and 2A-2D, the longitudinal member 30 is configuredto be attached to the first part 18 of the maxilla 14. In general, thelongitudinal member 30 includes a central bridge member 42 thatseparates the longitudinal member 30 into a first portion 46 and asecond portion 50. The first and second portions 46, 50 extend from thebridge member 42 from respective junctions 54. As shown, the firstportion 46 extends from the bridge member 42 in a first direction, whilethe second portion 50 extends from the bridge member 42 in a seconddirection that is generally opposite to the first direction. As bestshown in FIG. 2C, the first portion 46 and the second portion 50 eachcurves in the lateral direction A as they extend longitudinally.Therefore, as best shown in FIG. 2C, the longitudinal member 30 iscurved such that it forms generally a C-shaped structure. Furthermore,as best shown in FIGS. 2B and 2D, the first portion 46 and the secondportion 50 each angle up in the transverse direction T as they extendlongitudinally. The curvature and shape of the longitudinal member 30generally correspond to the shape of the maxilla 14.

Additionally, the first and second portions 46, and 50 of thelongitudinal member 30 include a plurality of fixation element receivingapertures/holes 58 that extend from the outer surface of thelongitudinal member 30 and through to the bone engaging surface. Eachhole 58 is configured to receive a fixation element, such as a screw.Though it should be understood that any fixation element will suffice.The implant 10 is configured to be fastened to the first part 18 of themaxilla 14 by inserting fixation elements through each hole 58 of thelongitudinal member 30 and into the first part 18 of the maxilla 14.

The bridge member 42 of the longitudinal member 30 includes a plate 62that is elongate in the longitudinal direction L, an extension 66extending in the lateral direction A from each end of the plate 62, anda centrally located protrusion 70 that also extends laterally from aninner surface of the plate 62. The junctions 54 are located at theposterior ends of each extension 66. Thus, the first and second portions46, 50 of the longitudinal member 30 each extend from a posterior end ofa respective extension 66 of the bridge member 42. The bridge member 42may be removed from the longitudinal member 30 at the junctions 54 oncethe implant 10 is secured to the maxilla 14. The junction points 54 maybe weakened so that the bridge member 42 may be easily removed once theimplant 10 is secured to the maxilla 14. For example, junctions 54 maybe thinned, or perforated, or otherwise configured, so that the bridgemember 42 may be removed by snapping the bridge member 42 away. Itshould be understood however that the bridge member 42 may be removed bycutting the junction points 54 with snips or pliers. Because the bridgemember 42 is removable, the amount of the implant 10 left in the patientmay be minimized.

As shown in FIG. 2B, the bridge member further includes a reference hole74 that extends laterally through both the plate 62 and the protrusion70 of the bridge member 42. The implant 10 may initially be fastened tothe maxilla 14 by inserting a fixation element through the referencehole 74 and into the maxilla 14. The fixation element inserted into thereference hole 74 may temporarily affix the implant 10 to the maxilla 14while a surgeon correctly aligns the implant 10 for complete fixation tothe maxilla 14.

The longitudinal member 30 and in particular the first and secondportions 46, 50, is pre-shaped to correspond to the post-operative shapeof the first part 18 of the maxilla 14. In this regard the longitudinalmember is pre-shaped prior to the segmentation procedure, so as tocorrespond to an outer surface of the first part of the maxilla afterthe segmentation procedure. While it is preferable that the member 30 ispre-shaped such that no manual bending is required prior to placement ofthe implant 10 onto the maxilla 14, the member 30 may be pre-shaped suchthat only minimal bending is required prior to placement of the implant10 onto the maxilla 14 (e.g. bending that may take place when fasteningthe member 30 to the maxilla 14). As best shown in FIG. 2C, the firstand second portions 46, 50 include several non-linear undulations 78that correspond to particular surface portions of the first part 18 ofthe maxilla 14. It should be understood, however, that the shape of thefirst part 18 of the maxilla 14 may be unchanged between thepre-operative and post-operative shape of the maxilla 14. Therefore, thelongitudinal member 30 may be pre-shaped to correspond to both thepre-operative shape and the post-operative shape of the first part 18 ofthe maxilla 14.

As shown in FIGS. 2A-2D, the holding structure 34 of the implant 10includes at least one finger 80, such as a plurality of fingers 80 thatextend up from the upper edge 38 of the longitudinal member 30. Inaccordance with the illustrative embodiment, two fingers 80 extend fromeach of the first and second portions 46, and 50 of the longitudinalmember 30. However, it should be understood that any number of fingers80 may extend up from the first and second portions 46, and 50. Asshown, each finger 80 includes at least one fixation element receivingaperture or hole 84 configured to receive a fixation element, such as ascrew, so as to affix the fingers 80 to the second part 22 of themaxilla 14. Though it should be understood any fixation element willsuffice. While the embodiment illustrated shows each finger 80 havingtwo holes 84, it should be understood, that each finger may have anynumber of holes, e.g. 1, 2, 3, 4, etc.

As best shown in FIG. 2B, the fingers 80 are spaced apart along thefirst and second portions 46, 50 of the longitudinal member 30 andextend substantially perpendicularly relative to the point on theportions 46, 50 from where they extend. That is, the longitudinal platemember 30 is non-linear and will define tangents at different pointsalong its edge 38. Therefore, each finger 80 will extend perpendicularwith respect to a tangent taken at the point on the edge 38 from whichthe finger 80 extends. Though it should be understood that the fingers80 do not have to extend perpendicularly, and may extend at some anglerelative to the longitudinal member 30. Preferably, each finger 80extends from the longitudinal member 30 such that a fixation elementhole 58 of the longitudinal member 30 is aligned with the point at whicha respective finger 80 extends from the edge 38 of the longitudinalmember 30, to further improve equal force distribution throughout theimplant 10.

The holding structure 34 or fingers 80 are pre-shaped to correspond tothe post-operative shape of the second part 22 of the maxilla 14, andextend from the first and second portions 46, 50, so as to provide afixation member that corresponds to the shape and the relationship ofthe first parts of the maxilla. In this regard the fingers 80 arepre-shaped prior to the segmentation procedure, so as to correspond toan outer surface of the second part of the maxilla after thesegmentation procedure. While it is preferable that the fingers 30 arepre-shaped such that no manual bending is required prior to placement ofthe implant 10 onto the maxilla 14, the fingers 80 may be pre-shapedsuch that only minimal bending is required prior to placement of theimplant 10 onto the maxilla 14. Therefore, as best shown in FIG. 2C, thefingers 80 include several non-linear undulations 90 that correspond toparticular surface portions of the second part 22 of the maxilla 14.Because the fingers 80 are pre-shaped, they will fit correctly only atthe desired location of the maxilla 14 and provide a surgeon withpositive assurance that they have achieved correct alignment and,therefore, a desired corrected shape.

Before the implant 10 is affixed to the maxilla, an osteotomy isperformed to separate the maxilla 14 into the first part 18 and thesecond part 22. A temporary osteotomy guiding implant 110 may be affixedto the maxilla 14 before the osteotomy is performed on the maxilla 14 tocreate a guide for the surgeon. In particular, the osteotomy guidingplate 110 provides a template for a surgeon to follow while performingthe osteotomy. For example, the osteotomy guiding implant 110 allows thesurgeon to make guide holes in the maxilla to follow while performingthe osteotomy. In this way, the osteotomy guiding implant acts as adrill guiding implant. The osteotomy guiding implant also provides atemplate for the surgeon to follow while implanting the bone implant 10.The osteotomy guiding implant 110 is also customized pre-operatively tominimize complications during surgery and time spent in the operatingroom by a patient.

As shown in FIGS. 3A-3D, the osteotomy guiding implant 110 includes alongitudinal plate member 130 that is elongate and curved in thelongitudinal direction L, and a template portion 132 that includes aplurality of fingers/protrusions 134 that extend vertically in thetransverse direction T from the longitudinal member 130. Like theimplant 10, the osteotomy guiding implant 110 includes an upper edge138, a bone engaging surface configured to lie substantially flush withthe maxilla, and an outer surface opposed to the bone engaging surface.The osteotomy guiding implant 110 and components thereof, can be formedfrom a variety of biocompatible materials, such as cobalt chromiummolybdenum (CoCrMo), titanium, and titanium alloys, stainless steel,ceramics, or polymers such as polyetheretherketone (PEEK),polyetherketoneketone (PEKK), and bioresorbable materials. A coating maybe added or applied to the osteotomy guiding implant 110 to improvephysical or chemical properties or to provide medications. Examples ofcoatings include plasma-sprayed titanium coating or Hydroxyapatite.

As best shown in FIG. 3C, the longitudinal plate member 130 includes afirst portion 146 and a second portion 150 that extend in oppositedirections from a central juncture 154. Each portion 146 and 150 curvesin the lateral direction A as it extends longitudinally. Therefore, asshown in FIG. 3C, the longitudinal member 130 is curved such that itforms generally a C-shaped structure similar to the bone fixationimplant 10. Furthermore, as best shown in FIGS. 3B and 3D, the firstportion 146 and the second portion 150 each angle up in the transversedirection T as they extend longitudinally. The curvature and shape ofthe longitudinal member 130 should be configured to correspond to theshape of the maxilla 14.

As shown in FIG. 3B, the longitudinal plate member 130 further includesa reference hole 174 that extends through the plate member 130 proximateto the central juncture 154 from the outer surface to the bone engagingsurface. The osteotomy guiding implant 110 may initially be fastened tothe maxilla 14 by inserting a fixation element through the referencehole 174 and into the maxilla 14. The fixation element inserted into thereference hole 174 may be temporary and is utilized while a surgeoncorrectly aligns the implant 110 so that an osteotomy guide may becreated.

As shown in FIGS. 3A-3D, the longitudinal plate member 130 defines aplurality of apertures or holes 176. As best shown in FIG. 3B, theembodiment illustrated includes three holes 176 in each portion 146 and150. The holes 176 are spaced apart and provide a template for thesurgeon to drill pre-holes into the maxilla 14 that will align with theholes 58 defined by the longitudinal member 30 of the bone implant 10.Therefore, the surgeon will know where to secure the bone implant 10 tothe first part 18 of the maxilla 14 after the osteotomy is performed byaligning the holes 58 of the bone implant 10 with the pre-drilled holes.Though it should be understood that in some cases, the longitudinalplate member 130 does not have the apertures 176, and thus thepre-drilled holes are not required to properly align the bone implant10.

As shown in FIGS. 3A-3D, the osteotomy guiding implant's fingers 134extend up from the upper edge 138 of the longitudinal member 130. Inparticular, two fingers 134 extend from each of the first and secondportions 146, and 150 of the longitudinal member 130. However, it shouldbe understood that any number of fingers 134 may extend up from thefirst and second portions 146, and 150.

As best shown in FIG. 3B, the fingers 134 are spaced apart along thelongitudinal member 130 and extend substantially perpendicularlyrelative to the point on the longitudinal member 130 from where theyextend. That is, the longitudinal member 130 is non-linear and willdefine tangents at different points along its edge 138. Therefore, thefingers 134 extend perpendicular with respect to a tangent taken at thepoint on the edge 138 from which the finger 134 extends. Though itshould be understood that the fingers 134 do not have to extendperpendicularly and may extend at an angle relative to the longitudinalmember 130.

As shown in FIG. 3B, each finger 134 of the osteotomy guiding implant110 defines an aperture or hole 180. The holes 180 are configured toreceive a drill bit so that guide holes may be drilled into the maxilla14 to thereby define a guide path along which the osteotomy may beperformed. As shown, the holes 180 of the fingers 134 will be positionedsuch that the guide path along which the osteotomy will be performed isappropriately located so that the bone fixation implant 10 may securelyhold the first part 18 of the maxilla 14 relative to the second part 22.That is, the osteotomy will be located such that the fingers 80 of thebone implant 10 will be long enough to extend across the osteotomy tosecurely hold the first part 18 of the maxilla relative to the secondpart 22.

The osteotomy guiding implant 110, and in particular the longitudinalmember 130 and the fingers 134, is pre-shaped to correspond to thepre-operative shape, and relative position of the first part 18 and thesecond part 22 of the maxilla 14. As best shown in FIG. 3C, thelongitudinal member 130 and the fingers 134 include several non-linearundulations 190 that correspond to particular portions of the first part18 and the second part 22 of the maxilla 14.

In reference to FIG. 4, both the bone fixation implant 10 and theosteotomy guiding implant 110 are manufactured and shapedpre-operatively. Prior to the orthognathic surgery being performed, a3-D image of the patient's skull, and in particular the patient'smaxilla, such as maxilla 14 is obtained. This may be completed with a CTscanning device 200 or the like, with slices smaller than 1mm preferred,and optimally between 0.2-1 mm. A high resolution for the slices ispreferred, since the exact shape of the maxilla 14 should be determinedfrom the CT scan slices. It will be appreciated that other scanningdevices 200 besides a CT scanning device may be used so long as theyprovide three dimensional data corresponding to the shape of the maxilla14.

Once the 3-D image of the patient's skull/maxilla is obtained, the imageis loaded into a computer 204 to create a virtual model of the skull formanipulation by a user such as the surgeon. The computer 204 may belocal (same general area as the CT scanning device 200) or remote wherethe image must be sent via a network. Similarly, the image loaded ontothe computer 204 may be manipulated by a user that is working locally orremotely. Typically, however, the image is manipulated remotely by thesurgeon who will be performing the orthognathic surgery.

The virtual model of the skull may be manipulated by the surgeon usingstandard software typical in the art. For example, Mimics, a softwarecommercially available from Materialise, having a place of business inLeuven Belgium, may be used to process and manipulate the virtual modelobtained from the CT scanning device 200. The software allows thesurgeon to analyze the patient's maxilla and pre-operatively plan thepatient's orthognathic surgery including the shape and design of thebone fixation implant a and an osteotomy guiding implant.

Using the virtual model of the patient's skull/maxilla, the surgeon mayfirst make a virtual model of an osteotomy guiding implant, such as theosteotomy guiding implant 110 shown in FIGS. 3A-3D. This is accomplishedby determining on the virtual model of the skull where the osteotomy isto be performed, and then actually performing a virtual osteotomy on thevirtual model. Once the virtual osteotomy is complete, the surgeon canbegin making the virtual model of the osteotomy guiding implant 110. Atthis point, it should be understood that the virtual model of the skulland in particular the maxilla still has its pre-operative shape andposition. Therefore, the longitudinal plate member 130 and the fingers134 of the osteotomy guiding implant 110 that is being made willcorrespond to the pre-operative shape of the patient's maxilla. Theholes 180 that are formed in the fingers 134 of the osteotomy guidingimplant 110 will be made in the virtual model to correspond to thevirtual osteotomy that was performed on the virtual model of the skull.Therefore, the osteotomy guiding implant 110 manufactured using thevirtual model, will define holes 180 that create a guide path for thesurgeon to follow while performing the osteotomy. In this way, theactual osteotomy performed on the patient will match the virtualosteotomy that was performed on the virtual model.

After the virtual model of the osteotomy guiding implant 110 iscomplete, the surgeon or other operator may manipulate the first part 18(the cut off portion) of the virtual model of the maxilla 14 from afirst undesired position to a second desired position. Once the firstpart 18 is positioned and the virtual model portrays the post-operativeshape and position of the patient's maxilla, as approved by the surgeon,a virtual model of a bone fixation implant, such as the bone fixationimplant 10 shown in FIGS. 2A-2D, can be made. At this point, it shouldbe understood that the virtual model of the skull and in particular themaxilla has a post-operative shape and position. Therefore, thelongitudinal plate member 30 and the fingers 80 of the bone fixationimplant 10 that is being made will correspond to the post-operativeshape of the patient's maxilla.

The virtual models of the osteotomy guiding implant 110 and the bonefixation implant 10 may be downloaded or transferred from the computer204 to a CAD/CAM milling/manufacturing machine 220 or the like. Themanufacturing machine 220 will machine the osteotomy guiding implant 110and the bone fixation implant 10 out of any desired material.

Once the osteotomy guiding implant 110 and the bone fixation implant 10have been manufactured, the surgeon may begin the orthognathic surgeryon the patient.

FIGS. 5A-5J show an example method of performing an orthognathic surgeryusing the osteotomy guiding implant 110 and the bone fixation implant10. It should be understood that prior to the surgery, the osteotomyguiding implant 110 and the bone fixation implant 10 are pre-shaped tosubstantially correspond to the individual patient's maxilla. FIG. 5Ashows an example skull 12 having a maxilla 14 that needs to berepositioned. FIG. 5B is a detailed view of the maxilla 14 shown in FIG.5A. As shown, the maxilla 14 at this point has a pre-operative shape. Anosteotomy is to be performed on the maxilla 14 to thereby separate themaxilla 14 into a first part 18 and a second part 22, so that the firstpart 18 can be repositioned, as will be described below.

As shown in FIG. 5C, the osteotomy guiding implant 110 may be placedonto the maxilla 14. As stated before, the osteotomy guiding implant 110is pre-shaped to correspond to the pre-operative shape of the maxilla14, and therefore will lie flush against the maxilla 14. In other wordsboth the longitudinal plate member 130 and the fingers 134 will bepre-shaped to correspond to the pre-operative shape of the maxilla 14.Once properly positioned, the osteotomy guiding implant 110 may betemporarily affixed to the maxilla 14 by inserting a screw 300 into thereference hole 174 of the osteotomy guiding implant 110 and screwing itinto the maxilla 14 with a driver 300.

As shown in FIG. 5D, the surgeon may then drill holes into the maxilla14 using a drill bit 304. As shown, the drill bit 304 may be insertedinto the holes 180 defined by the fingers 134 of the osteotomy guidingimplant 110. As stated before, the holes 180 are pre-planned andpositioned so that the surgeon can create a cutting path for the surgeonto follow while performing the osteotomy. For example, as shown in FIG.5E, four holes 320 are drilled into maxilla 14 using the osteotomyguiding implant 110. While four holes 320 are shown, it should beunderstood that the osteotomy guiding implant 110 may be configured sothat any number of holes 320 may be made using the osteotomy guidingimplant 110. For example, the osteotomy guiding implant 110 may be madeto have six fingers 134 so that six holes 320 may be made in themaxilla.

As shown in FIG. 5D, drill bit 304 or another drill bit may be insertedinto holes 176 defined by the longitudinal member 130 of the osteotomyguiding implant 110. As shown in FIG. 5E, six holes 324 are drilled intothe maxilla 14 using the osteotomy guiding implant 110. While six holes324 are shown, it should be understood that the osteotomy guidingimplant 110 may be configured so that any number of holes 324 may bemade using the osteotomy guiding implant 110. The holes 324 will act asa guide for the surgeon to properly place the bone implant 10 to themaxilla. To ensure that bone implant 10 will be securely affixed to themaxilla 14, the holes 324 are smaller than the holes 58 defined by thebone implant 10. Thus when a screw is affixed the threads of the screwwill grab a portion of the bone.

As shown in FIG. 5F, the osteotomy guiding implant 110 may be removedand the surgeon may perform an osteotomy 330 on the maxilla 14 along thecutting path created by the holes 320. In the embodiment illustrated,the cutting path extends from one hole 320 to an adjacent hole 320 untilthe osteotomy is complete. As shown in FIG. 5G, the osteotomy 330separates the maxilla into a first part 18 and a second part 22. Whilethe second part 22 remains intact with the skull, the first part 18 isfree to be repositioned by the surgeon, for example as shown in FIG. 5G.

Once the first part 18 of the maxilla 14 is repositioned, the bonefixation implant 10 may be placed onto the maxilla 14. As stated before,the bone fixation implant 10 is pre-shaped to correspond to thepost-operative shape of the maxilla 14, and therefore will lie flushagainst the maxilla 14 even after the first part 18 of the maxilla 14has been repositioned. In other words both the longitudinal plate member30 and the fingers 80 of the bone plate 10 will be pre-shaped tocorrespond to the post-operative shape of the maxilla 14. Once properlypositioned, the bone fixation implant 10 may be temporarily affixed tothe maxilla 14 by inserting a screw into the reference hole 74 of thebone fixation implant 10 and screwing it into the maxilla 14 with thedriver 300. In most cases the reference hole 74 of the bone fixationimplant 10 will line up with the hole created in the maxilla 14 by thescrew that was used to temporarily affix the osteotomy guiding implant110 to the maxilla 14.

As shown in FIGS. 5H and 5I, a plurality of screws 340 may be insertedinto the holes 58 and the holes 84 of the bone fixation implant 10. Asshown, the fingers 80 of the bone fixation implant 10 are affixed to thesecond part 22 of the maxilla 14 with the screws 340, and thelongitudinal member 30 of the bone fixation implant 10 is affixed to thefirst part 18 of the maxilla 14 with the screws 340. Therefore, the bonefixation implant 10 is affixed to the maxilla 14 on either side of theosteotomy 330.

As shown in FIG. 5J, the bridge member 42 may then be removed from thebone fixation implant 10 thereby separating the bone fixation implant 10into two separate parts 350. In this way, the bone fixation implant 10may be considered to be a single bone fixation implant 10 that isconfigured to be separated into two separate implant segments orsections after the bone fixation implant 10 has been affixed to bone. Asstated before, the bridge member 42 may be removed by either snapping itaway or by using pliers or snips to cut the bridge member away at thejunctions 54. It should be understood, however, that the bridge member42 may be removed using any method known in the art.

Once the bridge member 42 is removed, the bone fixation implant 10 iscompletely installed. Therefore, the surgery may be completed, and theimplant 10 may either remain within in the patient or be removed at alater time.

It should be understood that the bone fixation implant 10 and theosteotomy guiding implant 110 may be sold separately or as a kit. Itshould be understood, however, that the osteotomy guiding implant 110and bone fixation implant 10 may be manufactured and delivered atdifferent times even though they are part of the same kit. The kit mayalso include all of the fixation elements required to affix the bonefixation implant 10 to the maxilla 14 as well as any tools required tocomplete the procedure.

In another embodiment and in reference to FIG. 6 a bone fixation implant410 is designed to be fixed to an underlying bone such as a mandible414, for instance after the mandible 414 has been segmented into atleast a first bone part 418 and a second bone part 422 that is separatedfrom the first bone part 418 by a bone gap 426. For instance, the bonegap 426 can be created by a segmentation procedure, such as anosteotomy, or due to trauma, or a critical size defect for example. Thebone fixation implant 410 is configured to attach to the first andsecond parts 418 and 422, and thereby fix the first and second parts 418and 422 relative to each other so as to facilitate osteogenesis in thebone gap 426. The implant 410 is customized pre-operatively to reducecomplications during surgery and time spent in the operating room by apatient. It should be understood that the implant 410 may affix morethan two bone parts together.

As shown in FIGS. 7A-7E, the bone fixation implant 410 includes alongitudinal plate member 430 that is elongate and curved in thelongitudinal direction L and a plurality of guides 434 that are coupledto the plate member 430. The longitudinal plate member 430 includes abone engaging surface configured to abut the mandible, and an outersurface opposed to the bone engaging surface. As shown in FIG. 6, thebone fixation implant 410 connects and holds the first part 418 of themandible and the second part 422 of the mandible relative to each otherwhile osteogenesis occurs. The bone fixation implant 410 and componentsthereof, can be formed from a variety of biocompatible materials, suchas cobalt chromium molybdenum (CoCrMo), titanium, and titanium alloys,stainless steel, ceramics, or polymers such as polyetheretherketone(PEEK), polyetherketoneketone (PEKK), and bioresorbable materials. Acoating may be added or applied to the bone fixation implant 410 toimprove physical or chemical properties or to provide medications.Examples of coatings include plasma-sprayed titanium coating orHydroxyapatite.

As shown in FIGS. 6, and 7A-7E, the longitudinal plate member 430 isconfigured to wrap around the mandible 414 such that the plate member430 spans across the gap 426 and can be attached to both the first part418 and the second part 422 of the mandible 414. Therefore, as bestshown in FIG. 7A, the longitudinal plate member 430 is curved such thatit forms generally a C-shaped structure. Furthermore, the ends of theplate member 430 each angle up in the transverse direction T as theyextend longitudinally. The curvature and shape of the longitudinalmember 430 generally correspond to the shape of the mandible 414.

Additionally, the longitudinal member 430 includes a plurality offixation element receiving apertures/holes 458 that extend from theouter surface of the longitudinal member 430 and through to the boneengaging surface. Each hole 458 is configured to receive a fixationelement, such as a screw. Though it should be understood that anyfixation element will suffice. The implant 410 is configured to befastened to both the first part 418 and the second part 422 of themandible 414 by inserting fixation elements through holes 458 of thelongitudinal member 430 such that at least one fixation element engagesthe first part 418 of the mandible 414, and at least one fixationelement engages the second part 422 of the mandible 414.

As shown in FIGS. 7A and 7B, the plate member 430 further defines aplurality of recesses or indents 462 along upper and lower sides of theplate member 430. The recesses 462 allow the plate member 430 to bepre-bent to conform to the shape of the mandible 414.

In particular, the longitudinal member 430, may be pre-bent tocorrespond to the post-operative shape of the first part 418 and thesecond part 422 of the mandible 414. In this regard the longitudinalmember 430 is pre-bent prior to the segmentation procedure, so as tocorrespond to the general shape of the first and second parts of themandible 414 after the segmentation procedure. While it is preferablethat the member 430 is pre-bent such that no manual bending is requiredprior to placement of the implant 410 onto the mandible 414, the member430 may be pre-bent such that only minimal bending is required prior toplacement of the implant 410 onto the mandible 414 (e.g. bending thatmay take place when fastening the member 430 to the mandible 414). Itshould be understood, however, that the shape of the first part 418 andthe second part 422 of the mandible 414 may be unchanged between thepre-operative and post-operative shape of the mandible 414. Therefore,the longitudinal member 430 may be pre-bent to correspond to both thepre-operative shape/position and the post-operative shape/position ofthe first part 418 and the second part 422 of the mandible 414.

As shown in FIG. 7A, the guides 434 of the implant 410 are spaced aboutthe plate member 430 such that a guide 434 is coupled proximate to eachend of the plate member 430 and a guide 434 is coupled to the platemember 430 proximate to the gap 426 that is defined between the firstand second parts of the mandible 414. It should be understood that theguides 434 may be coupled anywhere along the plate member 430, asdesired.

As shown in FIGS. 7B-7E each guide 434 includes a guide body 480, apusher aperture 484 that extends transversely through the body 480, anda pusher 488 that is translatable within the pusher aperture 484. Asshown in FIG. 7C, the pusher aperture 484 is substantially rectangularshaped, though it should be understood that the transverse aperture 484may have any desired shape so long as the pusher 488 can translatewithin the aperture 484. As shown in FIGS. 7B and 7D, the guide body 480further includes a bore 492 that extends through a front face of thebody 480 and into the pusher aperture 484. The bore 492 is configured toreceive a set screw 496 that is configured to engage and lock the pusher488 in place.

As shown in FIG. 7D, the pusher 488 includes a transverse portion 500and a lateral portion 504 that extends from a bottom end of thetransverse portion 500 toward the mandible 414. Therefore, the pusher488 defines a substantially L-shaped structure. As shown , thetransverse portion 500 is configured to be received by the pusheraperture 484 and is translatable within the pusher aperture 484. Thetransverse portion 500 is substantially flat and includes an outercontact surface 508 that is configured to be engaged by the set screw496 when the pusher 488 is to be locked in place. The set screw 496 maybe a plug that may be pushed against the pusher 488 or may includethreads that engage threads defined by the bore 492. As shown in FIG.7D, the lateral portion 504 is also substantially flat and includes anupper bone contacting surface 512 that is configured to abut a bottom ofthe mandible 414 when the implant 410 is properly positioned. When thepusher 488 is translated vertically up within the pusher aperture 484,the bone contacting surface 512 moves closer to the guide body 480.Therefore, the position of the implant 410 (or at least the platemember) is adjustable depending on position of the pusher 488 within thepusher aperture 484.

As shown in FIGS. 7D and 7E the guide 434 further includes a platereceiving channel 516 that extends longitudinally through the guide body480. As shown in FIG. 7D, the channel 516 defines an opening 520 thatallows the guide 434 to be placed over the front outer surface of theplate member 430. As shown in FIG. 7E, the guide 434 further includes afixation receiving aperture 524 that extends through the body 480 andinto the channel 516. The fixation receiving aperture 524 is configuredto align with any one of the fixation receiving apertures 458 of theplate member 430. Therefore a fixation element 528 may be insertedthrough the aperture 524 of the guide 434 and into the aperture 458 ofthe plate member 430 to thereby affix the guide 434 to the plate member430. The guide 434 may be permanently or temporarily affixed to theplate member 430.

The guides 434 are pre-operatively configured so as to align the platemember 430 with the mandible when the implant 410 is positioned againstthe mandible after the mandible has been separated so as toe define thebone gap. In this regard the pusher 488 may be pre-adjusted prior to thesegmentation procedure, so that when the implant 410 is positionedagainst the mandible 414, the plate member 430 is properly aligned withthe first part 418 and the second part 422 after the segmentationprocedure. While it is preferable that the pusher 488 is pre-adjustedsuch that no additional adjustments are required prior to placement ofthe implant 410 onto the mandible 414, the pusher 488 may bepre-adjusted such that only minimal further adjustment is required priorto placement of the implant 410 onto the mandible 414. Because thepushers 434 are pre-adjusted, the implant 410 will fit correctly only atthe desired location of the mandible 414 and provide a surgeon withpositive assurance that they have achieved correct alignment and,therefore, a desired corrected shape.

In another embodiment and in reference to FIGS. 8A and 8B, the bonefixation implant 410 may include a plurality of guides 574. As shown,each guide 574 includes a guide body 580 that is pre-configured orotherwise pre-shaped to correspond to the post-operative shape of themandible 414. As shown, the guide body 580 is separated into at least aplate member fixation portion 584 and an alignment portion 588. Asshown, the guide 574 further includes a fixation receiving aperture 592that extends through the plate member fixation portion 584. The aperture592 is configured to align with any one of the fixation apertures 458 ofthe plate member 430 such that a fixation element 594 may pass throughthe aperture 592 and into the aperture 458 to thereby couple the guide574 to the plate member 430. The guide body 580 may be over-molded to bepermanently attached to the plate member 430 or may be over-molded tocorrespond to the shape of the plate member 430 so that when the guide580 is attached to the plate member 430, the fixation portion 584 willlie flush against the plate member 430.

As shown in FIGS. 8A and 8B, the alignment portion 588 extends from thefixation portion 584 such that the alignment portion 588 is configuredto abut an outer surface of the mandible 414. As shown in FIG. 8B, thealignment portion 588 defines an inner bone contacting surface 596 thatis pre-operatively shaped to correspond to the post-operative shape ofthe mandible 414. That is, each guide body 580 is pre-operatively shapedto correspond to a specific portion of the mandible so as to align theplate member 430 with the mandible when the implant is positionedagainst the mandible after the mandible has been separated.

In this regard the guide bodies 580 are pre-shaped prior to thesegmentation procedure, so as to correspond to an outer surface of aportion of the mandible 414 after the segmentation procedure. While itis preferable that the guide bodies 580 are pre-shaped such that nomanual bending is required prior to placement of the implant 410 ontothe mandible 414, the guide bodies 580 may be pre-shaped such that onlyminimal bending is required prior to placement of the implant 410 ontothe mandible 414. Therefore, alignment portion 588 or at least the bonecontacting surface 596 of the alignment portion 588 defines severalnon-linear undulations 600 that correspond to particular surfaceportions of the mandible 414. Because the guide bodies 580 arepre-shaped, they will fit correctly only at the desired location of themandible 414 and provide a surgeon with positive assurance that theyhave achieved correct alignment of the implant.

Similar to the bone implant 10, the bone implant 410 is manufactured andconfigured pre-operatively. Prior to the orthognathic surgery beingperformed, a 3-D image of the patient's skull, and in particular thepatient's mandible, such as mandible 414 is obtained. This may becompleted with a CT scanning device (such as device 200 shown in FIG. 4)or the like, with slices smaller than 1mm preferred, and optimallybetween 0.2-1 mm. A high resolution for the slices is preferred, sincethe exact shape of the mandible 414 should be determined from the CTscan slices. It will be appreciated that other scanning devices 200besides a CT scanning device may be used so long as they provide threedimensional data corresponding to the shape of the mandible 414.

Once the 3-D image of the patient's skull/mandible is obtained, theimage is loaded into a computer (such as computer 204 shown in FIG. 4)to create a virtual model of the skull for manipulation by a user suchas the surgeon. The computer 204 may be local (same general area as theCT scanning device 200) or remote where the image must be sent via anetwork. Similarly, the image loaded onto the computer 204 may bemanipulated by a user that is working locally or remotely. Typically,however, the image is manipulated remotely by the surgeon who will beperforming the orthognathic surgery.

The virtual model of the skull may be manipulated by the surgeon usingstandard software typical in the art. For example, Mimics, a softwarecommercially available from Materialise, having a place of business inLeuven Belgium, may be used to process and manipulate the virtual modelobtained from the CT scanning device 200. The software allows thesurgeon to analyze the patient's mandible and pre-operatively plan thepatient's orthognathic surgery including the shape and/or configurationof the bone fixation implant 414.

Using the 3-D model the surgeon or other operator may manipulate themandible 414 by (i) cutting the mandible 414 to form the gap 426, (ii)repositioning the first part 418 of the mandible 414 from a firstundesired position to a second desired position, and/or (iii)repositioning the second part 422 of the mandible 414 from a firstundesired position to a second desired position. Once the first part 418and/or the second part 422 are positioned and the virtual model portraysthe post-operative shape and position of the patient's mandible, asapproved by the surgeon, a virtual model of a bone fixation implant,such as the bone fixation implant 410 shown in FIGS. 7A-7E or 8A and 8B,can be made. At this point, it should be understood that the virtualmodel of the skull and in particular the mandible has a post-operativeshape and position. Therefore, the longitudinal plate member 430 and theguides 434 or 474 of the bone fixation implant 410 that is being madewill correspond to the post-operative shape/position of the patient'smandible.

For bone fixation implants 410 that include a guide 434, the virtualmodel of the bone fixation implant 410 may be downloaded and the pusher488 of the guide 434 may be pre-configured or otherwise pre-adjusted tomatch that of the model. For bone fixation implants 410 that include aguide body 574, the virtual model of the implant 410 is transferred fromthe computer 204 to a CAD/CAM milling/manufacturing machine (such asmachine 220 shown in FIG. 4) or the like. The manufacturing machine 220will machine the guide 574 out of any desired material to conform to thepost-operative shape of the mandible 414. Once the guide 434 has beenadjusted, or the guide 574 has been milled, the surgeon may begin theorthognathic surgery on the patient.

FIGS. 9A-9E show an example method of performing an orthognathic surgeryusing the bone fixation implant 410. It should be understood that priorto the surgery, the bone fixation implant 410 is pre-configured tosubstantially correspond to the individual patient's mandible. FIG. 9Ashows an example mandible 414 that needs to be repositioned. As shown,the mandible 414 at this point has a pre-operative shape. An osteotomyis to be performed on the mandible 414 to thereby separate the mandible414 into a first part 418 and a second part 422 as shown n FIG. 9B.

Once the osteotomy is performed and the gap 426 is made, if needed, thefirst part 418 and/or the second part 422 of the mandible 414 may berepositioned to the post-operative shape. The bone fixation implant 410may then be placed onto the mandible 414. As stated before, the bonefixation implant 410 is pre-configured to correspond to thepost-operative shape of the mandible 414, and therefore will be properlyaligned when in place. As shown in FIG. 9C, for embodiments that includeguides 434, the upper bone contacting surfaces 512 of the pushers 488will each abut the bottom surface of the mandible 414 once the implant410 is properly positioned.

Alternatively, for embodiments that include guides 574, the alignmentportions 588 of the guides 574 will lie flush against the mandible 414when the implant 410 is properly positioned.

As shown in FIGS. 9C and 9D, once properly positioned, a plurality ofscrews 640 may be inserted into the fixation apertures 458 of the platemember 430. As shown, the plate member 430 is affixed to both the firstpart 418 and the second part 422 of the mandible 414. Therefore, thebone fixation implant 410 is affixed to the mandible 414 on either sideof the gap 426.

As shown in FIG. 9E, the guides 434 (or guides 574) may then be removedfrom the bone fixation implant 410 thereby leaving the plate member 430affixed to the mandible 414. Therefore, the surgery may be completed,and the implant 10 may either remain within in the patient or be removedat a later time.

It will be appreciated by those skilled in the art that changes could bemade to the embodiments described above without departing from the broadinventive concept thereof. It is understood, therefore, that thisinvention is not limited to the particular embodiments disclosed, but itis intended to cover modifications within the spirit and scope of thepresent invention as defined by the present description. For example,while the bone fixation implant 10 is shown as having a removable bridgemember 42, it should be understood that the bone fixation implant mayremain intact after it has been installed. In other words, thelongitudinal member 30 of the bone fixation implant 10 may be a singlecontinuous plate that is configured to remain a single piece afterinstallation of the bone plate 10. Furthermore, while the holes 180 ofthe osteotomy guiding implant 110 are positioned in the fingers 134 ofthe implant 110 such that a guide path is created for the osteotomy tobe performed along the holes, the holes 180 may be positioned to createan alternative guide. For example, the holes 180 may be positioned tocreate holes in the maxilla 14 that line up with the holes 58 defined bythe longitudinal member 30 of the bone fixation implant 10. In such acase the osteotomy would be performed above the holes 180. Furthermore,while the bone fixation implant 10 and the osteotomy guiding implant 110have been described for use in orthognathic surgeries involving themaxilla, and the bone fixation implant 410 has been described for use inorthognathic surgeries involving the mandible should be understood thatthe bone fixation implant 10 and the osteotomy guiding implant 110 maybe used in orthognathic surgeries involving the mandible, and the bonefixation implant 410 may be used in orthognathic surgeries involving themaxilla. Additionally, the bone fixation implant 10, the osteotomyguiding implant 110, the bone fixation implant 410 and the describedconcepts are not limited to orthognathic surgeries and may be utilizedin surgeries for other parts of the body that may need to affix a firstsegmented portion of bone relative to a second integral portion of bone.

What is claimed is:
 1. An implant configured to fix at least a firstmandibular bone part relative to a second mandibular bone part that isseparated from the first mandibular bone part by a bone gap, the implantcomprising: a plate member including a pre-operatively bent body havinga shape corresponding to a post-operative shape of a mandible whenaligned with the mandible, the plate member defining at least onefixation aperture that extends through the pre-operatively bent body andis configured to receive a bone fixation element so as to secure theplate member to the mandible; and at least one guide coupled to theplate member, the at least one guide pre-operatively configured to alignthe plate member with the mandible when the implant is positionedagainst the mandible after the mandible has been separated so as todefine the bone gap.
 2. The implant of claim 1, wherein the at least oneguide includes a guide body that is pre-shaped to correspond to thepost-operative shape of the mandible.
 3. The implant of claim 2, whereinthe guide body includes an alignment portion that defines an inner bonecontacting surface that is pre-shaped to correspond to thepost-operative shape of the mandible so as to align the plate memberwith the mandible when the implant is positioned against the mandibleafter the mandible has been separated into at least the first and secondbone parts.
 4. The implant of claim 2, wherein the guide body is madefrom a biocompatible material.
 5. The implant of claim 2, wherein theimplant includes three guides, each guide having a guide body that ispre-shaped to correspond to the post-operative shape of the mandible soas to align the plate member with the mandible when the implant ispositioned against the mandible after the mandible has been separatedinto at least the first and second bone parts.
 6. The implant of clam 1,wherein the at least one guide includes a guide body, and a fixationelement aperture that extends through the guide body, the fixationelement aperture configured to receive a fixation element to temporarilycouple the guide to the plate member.
 7. The implant of claim 1, whereinthe plate member includes at least one aperture configured to receive afixation element to thereby affix the implant to the mandible.
 8. Theimplant of claim 1, wherein the at least one guide includes a guidebody, a pusher aperture that extends transversely through the guidebody, and a pusher that is disposed within the pusher aperture, thepusher configured to abut a bottom of the mandible so as to align theplate member with the mandible when the implant is positioned againstthe mandible after the mandible has been separated into at least thefirst and second bone parts.
 9. The implant of claim 8, wherein thepusher is adjustable along the transverse direction within the pusheraperture.
 10. The implant of claim 9, wherein the at least one guidefurther includes a bore that extends laterally through the guide bodyand into the pusher aperture, the bore configured to receive a set screwto thereby lock the pusher to the guide body.
 11. The implant of claim8, wherein the at least one guide further includes a bone platereceiving channel that extends longitudinally through the guide body,the bone plate receiving channel configured to receive the bone platewhen the at least one guide is coupled to the bone plate.
 12. Theimplant of claim 8, wherein the pusher includes a transverse portion anda lateral portion that extends from a distal end of the transverseportion toward the mandible.
 13. The implant of claim 8, wherein thepusher defines a bone contacting surface that is configured to abut themandible when the implant is positioned against the mandible.